Skip to main content
OpenTrials
Completed

NCT Number: NCT00446992

Diabetes in Neuropsychiatric Disorders

The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.

We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170

Barcelona, 08036, Spain

About this study

Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Age 18-64
  • Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study
  • No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease),
  • Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics)
  • No history of cocaine use in the previous 30 days, and
  • No laboratory evidence of diabetes at baseline (fasting glucose <126 mg/dL or 2-hour glucose <200 mg/dL on a glucose tolerance test)

Treatment and study plan

Olanzapine

Drug

16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.

Other names: Zyprexa, Zydis, Relprevv

Primary outcomes

  1. Body Mass Index

    Time frame: Baseline and 4 week intervals

  2. Fasting Glucose

    Time frame: Baseline and 4 week intervals

  3. Fasting Insulin

    Time frame: Baseline and 4 week intervals

  4. Hemoglobin A1c

    Time frame: Baseline and 4 week intervals

  5. IL-6

    Time frame: Baseline and 4 week intervals

  6. Triglycerides

    Time frame: Baseline and 4 week intervals

  7. Cholesterol Total

    Time frame: Baseline and 4 week intervals

  8. HDL

    Time frame: Baseline and 4 week intervals

  9. LDL

    Time frame: Baseline and 4 week intervals

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 13, 2007
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.